FDA Medical devices recall ·
Galaxy bronchoscope (Product GALB-001) used with Instructions for use… recall
- Recall number
- Z-0679-2025
- Date
- (initiated October 25, 2024)
- Company / brand
- Noah Medical
1501 Industrial Rd, San Carlos, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 26
- Hazard tags
- Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
Why was it recalled?
Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00850048825048. IFU Revision: J and all prior versions. All bronchoscope lots used with the following system serial numbers: CRB-1502, CRB-1503, CRB-1508, CRB-1513, CRB-1514, CRB-1515, CRB-1516, CRB-1518, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1528, CRB-1530, CRB-1532, CRB-1534, CRB-1535, CRB-1537, CRB-1538, CRB1540, CRB-1541, CRB-1543, CRB1554
Distribution
US Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC
States: California Connecticut Idaho Indiana Massachusetts Maryland Missouri North Carolina New Jersey New York Ohio Pennsylvania South Carolina Tennessee West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0679-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.